Certification And Requirements - Invacare ScanBeta NG Manuel D'utilisation

1.2 Certification and requirements

Invacare® is certified according to DS/EN ISO 9001 and ISO 13485.
This ensures the customers, that the product is always supplied in a uniform quality.
Throughout the entire production process the materials and products are quality controlled by the operators.
Once the product is assembled, a final test is carried out. The operator performing the test, which also includes checking all moving
parts, motors and castors, signs the receipt for the product with his/her personal QA-number.
If the product does not meet Invacare® stipulated quality requirements, the product will be rejected.
If, contrary to our expectations, there should be any problem with the product, please contact your local Invacare® supplier.
The ScanBeta NG cot is CE-marked in accordance with Directive 93/42/EEC on medical equipment.
The ScanBeta NG cot has undergone risk assessment in accordance with EN ISO14971:2008.
The ScanBeta NG cot has been approved in accordance with the Nordic Requirement Specification.
The ScanBeta NG cot has been approved in accordance with EN 60601:1996-03 and EN60601-1-2.
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